(6 days)
Not Found
No
The description details a conventional electric scooter with basic electronic controls and diagnostic indicators, with no mention of AI or ML capabilities.
No.
The device provides mobility to persons in a seated position but does not actively treat or diagnose a medical condition.
No
The device description indicates that the scooter has a status indicator that provides diagnostic information for the scooter itself (e.g., fault detection in the controller or wiring). This is diagnostic information about the machine's operation and not about a person's health or medical condition. The primary purpose of the device is mobility.
No
The device description clearly outlines a physical, motor-driven vehicle with a steel frame, transaxle motor drive system, braking system, and other hardware components. While it includes an electronic motor controller and a status indicator, these are integral parts of the physical hardware and not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To provide mobility to persons limited to a seated position." This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a motor-driven vehicle for transportation. It does not mention any components or processes related to analyzing biological specimens (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents
- Assays
- Analysis of biological samples
- Diagnostic results or interpretations
The device is clearly a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The intended use of the Adventure scooters is to provide mobility to persons limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The Invacare Adventure Series of Scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to persons limited to a seated position.
The scooters are basic conventional rear wheel drive, rigid frame vehicles that are battery powered. Various options and accessories are available depending upon user needs and preferences. They consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They also include a tiller handle for steering and a throttle control to engage and disengage the scooter motion in both the forward and reverse directions. The scooters can also be disassembled for ease of transport, are powered by two (2) 12 volt DC batteries, and utilize an on-board charger.
The scooters have a status indicator located on the face of the control panel that provides diagnostic information. The status LED will flash a certain number of times, separated by a pause when a fault is detected in the controller or in the wiring. This feature is for diagnostic information only and does not control the operation of the scooter.
The Adventure SX-3 is a compact version of the scooter with a 250 lb. weight capacity while the Adventure LX-3 scooter is a mid-size version of the scooter with a 350 lb. weight capacity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Invacare Models Lynx and Panther scooters meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs. The upholstery materials meet California 116 and 117 specifications for fire retardancy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
0
MAR 2 0 2003
510(k) SUMMARY INVACARE CORPORATION'S 510(k) PREMARKET NOTIFICATION ADVENTURE MOTORIZED SCOOTERS
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person: Rae Ann Farrow Manager, Regulatory Compliance
Date Prepared: March 13, 2003
Name of Device and Name/Address of Sponsor:
Name of Device: Invacare Adventure Series Scooters
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 366-9724
Common or Usual Name
Scooter
Classification Name
Motorized Three Wheel Vehicle
Predicate Devices
The Adventure Scooters are substantially equivalent to the Lynx scooters (K010135, 2/16/2001).
Intended Use
The intended use of the Adventure scooters is to provide mobility to persons limited to a seated position.
1
Technological Characteristics and Substantial Equivalence
Device Description
The Invacare Adventure Series of Scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to persons limited to a seated position.
The scooters are basic conventional rear wheel drive, rigid frame vehicles that are battery powered. Various options and accessories are available depending upon user needs and preferences. They consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They also include a tiller handle for steering and a throttle control to engage and disengage the scooter motion in both the forward and reverse The scooters can also be disassembled for ease of transport, are directions. powered by two (2) 12 volt DC batteries, and utilize an on-board charger.
The scooters have a status indicator located on the face of the control panel that provides diagnostic information. The status LED will flash a certain number of times, separated by a pause when a fault is detected in the controller or in the wiring. This feature is for diagnostic information only and does not control the operation of the scooter.
The Adventure SX-3 is a compact version of the scooter with a 250 lb. weight capacity while the Adventure LX-3 scooter is a mid-size version of the scooter with a 350 lb. weight capacity.
Substantial Equivalence
Products, which are substantially equivalent to the Invacare Adventure scooters, include the Invacare Lynx SX-3, Lynx LX-3, and Lynx LX-3P06 scooters, which were granted clearance by FDA on February 16, 2001 on 510(k) accession number K010135. Each of these products are motorized, 3-wheel scooters with the same intended function and use of providing mobility to persons limited to a seated position.
While there are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Invacare believes that the Adventure series of scooters are substantially equivalent to legally marketed devices currently in commercial distribution.
Performance Data
The Invacare Models Lynx and Panther scooters meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs. The upholstery materials meet California 116 and 117 specifications for fire retardancy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
MAR 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, OH 44036-2125
Re: K030814
Trade/Device Name: Invacare Adventure Series Scooters Regulation Number: 890.38002 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: March 13, 2003 Received: March 14, 2003
Dear Ms. Farrow:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Ms. Rae Ann Farrow
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): TBD
Device Name: Invacare Adventure Series Scooters
Indications For Use: To provide mobility to persons limited to a seated position.
Mark N Williamson
Division Signn. Restorative Division of Ge: and Neurologica. Devices
14 " 10(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use √
(Optional Format 1-2-96)